Tonica Elektronik A/S FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
MagVenture Accelerated TMS (aTMS) Therapy System510(k)May 22, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 22, 2026
MagVenture TMS Therapy System510(k)Aug 11, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 11, 2025
MagVenture TMS Therapy System510(k)Aug 8, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 8, 2025
T65 (9016E061-)510(k)Jul 30, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jul 30, 2025
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption510(k)Aug 25, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2023
MagVenture TMS Atlas Neuro Navigation System510(k)Mar 17, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 17, 2023